A Process Validation Study To Prevent Re-generation Of Dimers In The Production Of Recombinant Human Interferon Alpha 2b

Verification is a series of activities to prove the expected results from any operation(or method), test method, and production process or system. In recent years, as the repaid progress of science and technology in biology and its extensive practices in pharmaceutical areas, people's recognition is more in depthinto measures of drug production and quality assurance, legal awareness is gradually sound, the qualityawareness of biology drugs from the user is improved gradually, supervision of drugs is enhanced, the content of good manufacturing practice(GMP) is made more perfect day by day, and the importance of verification is recognized gradually by pharmaceutical producer big or small around the world. The importance of verification is to be increasingly vital, not only on the satisfaction of the requirement indrug policy,also on the assurance of drug quality.In the thesis, we started the discussion with the origin of process verification, and deepened into the discussion about the meaning as well as the ultimate goal of introducing the process verification into the GMP, on the basis of the understanding on the origin, the content, the practice and the latest progresses of process verification. And we focused the discussion on how to carry out the process verification under the request of<<Goods Mamufacturing Practice for pharmaceutical products(Amended in 2010) >>. In the end, an example was given: Dimer was formed in the production process of recombinant human interferon ?2b. An method was supplied through a series of trialsto avoid the formation of dimer of recombinant human interferon ?2b. This is taken as the case of process verification.